Dextromethorphan Polistirex Extended-Release

Description

The product is presented in a 3 oz carton, containing a solution with a concentration of 30 mg per 5 mL. Each carton includes a label that specifies this dosage form.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or as a result of inhaled irritants. Additionally, it is indicated for the temporary relief of the impulse to cough, facilitating sleep.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The bottle should be shaken well before each use. Dosing must be measured exclusively with the dosing cup provided; the use of this cup with other products is not recommended.

For dosing, the following guidelines should be adhered to, unless otherwise directed by a healthcare professional:

• Adults and children 12 years of age and over: Administer 10 mL every 12 hours, with a maximum dosage of 20 mL within a 24-hour period.

• Children 6 to under 12 years of age: Administer 5 mL every 12 hours, with a maximum dosage of 10 mL within a 24-hour period.

• Children 4 to under 6 years of age: Administer 2.5 mL every 12 hours, with a maximum dosage of 5 mL within a 24-hour period.

• Children under 4 years of age: The product is not recommended for use.

It is essential to follow these dosing instructions carefully to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Warnings It is imperative to adhere to the warnings outlined for safe usage.

General Precautions This product must not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be taken for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is essential to consult a healthcare provider or pharmacist prior to using this product.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be established without delay.

Monitoring and Consultation Patients should discontinue use and consult a healthcare provider if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this medication. It is crucial to stop use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate the presence of a serious underlying condition that requires medical evaluation.

In clinical practice, monitoring for these signs is essential to ensure patient safety and to facilitate timely intervention if necessary. The importance of recognizing these symptoms cannot be overstated, as they may signify complications that warrant further investigation and management.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Patients should not initiate treatment with this product if they are currently taking an MAOI or have discontinued an MAOI within the past two weeks.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before using this product. This precaution is critical to avoid potential adverse interactions that may arise from the combination of these agents.

Packaging & NDC

Below are the non-prescription pack sizes of Dextromethorphan Polistirex Extended-Release (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 6 years, the recommended dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in a 24-hour period. In children aged 6 to under 12 years, the dosage increases to 5 mL every 12 hours, not to exceed 10 mL in 24 hours. For adolescents and adults aged 12 years and over, the dosage is 10 mL every 12 hours, with a maximum of 20 mL in 24 hours. Care should be taken to adhere to these dosing guidelines to ensure safety and efficacy in pediatric populations.

Geriatric Use

Elderly patients may be treated with Dextromethorphan Polistirex Extended-Release Suspension; however, there are no specific recommendations for geriatric use, including dosage adjustments or safety concerns. The prescribing information does not indicate any special precautions that need to be taken when administering this medication to patients aged 65 and older.

Healthcare providers should continue to monitor elderly patients for any potential adverse effects, as individual responses to medication can vary. It is advisable to exercise clinical judgment when prescribing this medication to geriatric patients, considering their overall health status and any concomitant medications they may be taking.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions indicated for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may be beneficial in guiding the management of the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. The following events have been documented: dizziness, nausea, vomiting, somnolence, confusion, hallucinations, agitation, rash, pruritus, urticaria, and anaphylaxis. These reactions were reported during the postmarketing experience and may not be directly related to the use of the product.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Providers should also recommend that patients consult a doctor before using this medication if they have a chronic cough that persists, particularly if it is associated with smoking, asthma, or emphysema, or if they have a cough that produces excessive phlegm (mucus).

Patients should be instructed to discontinue use and seek medical advice if their cough lasts more than 7 days, if it returns after improvement, or if it is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a more serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dextromethorphan Polistirex Extended-Release, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)